Neuraceq
florbetaben (18F)
florbetaben (18F)
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your nuclear medicine doctor who will supervise the procedure.
If you get any side effects, talk to your nuclear medicine doctor. This includes any possible side
effects not listed in this leaflet. See section 4.
What Neuraceq is and what it is used for
What you need to know before Neuraceq is used
How Neuraceq will be used
Possible side effects
How Neuraceq is stored
Contents of the pack and other information
This medicine is a radiopharmaceutical product for diagnostic use only. Neuraceq contains the active substance florbetaben (18F).
Neuraceq is given to people with memory problems so that doctors can perform a type of brain scan, called a PET scan. A Neuraceq PET scan, along with other brain function tests, can help your doctor determine whether or not you may have β-amyloid plaques in your brain. This medicine is intended for adults only.
You should discuss the results of the test with the doctor that requested the scan.
The use of Neuraceq does involve exposure to small amounts of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit of this procedure with the radiopharmaceutical outweighs the risk of being exposed to radiation.
if you are allergic to florbetaben (18F) or any of the other ingredients of this medicine (listed in section 6).
Talk to your nuclear medicine doctor before you are given Neuraceq if you:
have kidney problems
have liver problems
are pregnant or think you may be pregnant
are breast-feeding
Neuraceq is not intended for use in children and adolescents below the age of 18 years old.
Tell your nuclear medicine doctor if you are taking, have recently taken or might take any other medicines since they may interfere with the interpretation of the images from the PET scan.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your nuclear medicine doctor for advise before you are given this medicine.
You must inform the nuclear medicine doctor before you are given Neuraceq if there is a possibility you might be pregnant, if you have missed your period or if you are breast-feeding. When in doubt, it is important to consult your nuclear medicine doctor who will supervise the procedure.
Pregnant
The nuclear medicine doctor will only give this medicine during pregnancy if a benefit is expected which would outweigh the risks.
Breast-feeding
You must stop breast-feeding for 24 hours after the injection. Express breast milk during this period and discard the breast milk you have expressed. Resuming breast-feeding should be in agreement with the nuclear medicine doctor who will supervise the procedure.
Neuraceq has no influence on the ability to drive and use machines.
This medicine contains 15 vol % ethanol (alcohol), i.e. up to 1.2 g per dose, equivalent to 30 mL beer or 12.5 mL wine per dose.
Harmful for those suffering from alcoholism, and is also to be taken into account in pregnant or
breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
This medicine contains up to 33 mg sodium (main component of cooking/table salt) in each
dose. This is equivalent to 1.6% of the recommended maximum daily dietary intake of sodium for an adult.
There are strict laws on the use, handling and disposal of radiopharmaceutical products.
Neuraceq will only be used in specially controlled areas. This medicine will only be handled and given to you by professionals who are trained and qualified to use it safely. These persons will take special
care for the safe use of this medicine and will keep you informed of their actions.
The nuclear medicine doctor supervising the procedure will decide on the amount of Neuraceq to be used in your case. It will be the smallest amount necessary to get the desired information.
The quantity to be administered usually recommended for an adult is 300 MBq (megabecquerel, the unit used to express radioactivity).
Neuraceq is given as an injection into your vein (intravenous injection) followed by a flush of sodium chloride solution to ensure full delivery of the dose.
One injection is sufficient to carry out the scan that your doctor needs.
A brain scan is usually taken 90 minutes after Neuraceq is given.
Your nuclear medicine doctor will inform you about the usual duration of the procedure.
Avoid any close contact with young children and pregnant women for 24 hours following the injection.
The nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine. Contact your nuclear medicine doctor if you have any questions.
An overdose is unlikely since you will only receive a single dose of Neuraceq precisely controlled by the nuclear medicine doctor supervising the procedure.
However, in the case of an overdose, you will receive the appropriate treatment. In particular, the nuclear medicine doctor in charge of the procedure may provide ways to increase the passing of urine and stools in order to help remove radioactivity from your body.
If you have any further questions on the use of this medicine, please ask your nuclear medicine doctor who supervises the procedure.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Possible side effects include:
Injection site reactions: injection site pain, redness of the skin at injection site (injection / application site erythema)
Burning sensation, headache, neuralgia (intense, typically intermittent pain along the course of a nerve), tremor (an involuntary quivering movement)
Vessels: flushing (sudden reddening of the face and/or neck), haematoma (a bruise, a black and
blue mark), hypotension (low blood pressure)
Stomach: diarrhea, nausea (feeling sick)
Liver: abnormal liver function
Skin: hyperhidrosis (excessive sweat), rash, toxic skin eruption (acute skin affections with measles-type erythema of the skin, potentially including blisters and ulcerations)
Muscles and bones: limb discomfort, pain in extremity
Injection site conditions: injection site irritation, pain and discomfort around the injection site, injection site haematoma (a bruise, a black and blue mark at injection site), injection site
warmth, tiredness, feeling hot, pyrexia (raised body temperature, a fever)
Abnormal blood test: increased blood creatinine levels (reduced kidney function)
This radiopharmaceutical will deliver low amounts of ionising radiation associated with the least risk of cancer and hereditary abnormalities.
If you get any side effects please talk to your nuclear medicine doctor. This includes any side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
You will not have to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate premises. Storage of radiopharmaceuticals will be in accordance with national regulation on radioactive materials.
The following information is intended for the specialist only:
Keep out of the sight and reach of children.
Do not use after the expiry date which is stated on the box, shield label and vial label after EXP.
This medicine does not require any special storage conditions.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
The active substance is florbetaben (18F). Each mL of solution for injection contains 300 MBq of florbetaben (18F) at the date and time of calibration. The activity per vial ranges from 300
MBq to 3000 MBq at the date and time of calibration.
The other ingredients are ascorbic acid, ethanol anhydrous, macrogol 400, sodium ascorbate, and water for injections (see section 2 “Neuraceq contains ethanol and sodium ascorbate”).
Neuraceq is a clear, colourless solution for injection. It is supplied in a colourless 15 mL glass vial, sealed with a rubber stopper and aluminium seal.
Each multidose vial contains 1 to 10 mL of solution, corresponding to 300 to 3000 MBq of florbetaben (18F) at the date and time of calibration.
Pack size of 1 vial.
12489 Berlin Germany
BV Cyclotron VU | ||
De Boelelaan 1081 | ||
1081 HV Amsterdam | ||
The Netherlands | ||
Curium PET France CHU Brabois
4 rue du Morvan
54500 Vandoeuvre les Nancy France
Curium PET France
Parc scientifique Georges Besse 180 allée Von Neumann
30000 Nîmes France
Curium PET France
14 rue de la Grange aux Belles 75010 Paris
France
Curium PET France
avenue de la Bataille Flandres Dunkerque, CS 44229 35000 Rennes
France
Curium PET France CHU Xavier Arnozan avenue du Haut-Lévèque 33604 Pessac
France
Life Radiopharma Berlin GmbH Max-Planck-Strasse 4
12489 Berlin Germany
Life RadiopharmaWarszawa Sp. z o.o. ul. Szeligowska 3
05-850 Szeligi Poland
Life Radiopharma Bonn GmbH Spessartstr. 9
53119 Bonn Germany
Curium Italy S.R.L. via Pergolesi, 33
20900 Monza Italy
Curium Italy S.R.L.
Viale Oxford 81 (loc. Tor Vergata) 00133 Rome
Italy
Curium Italy S.R.L.
Piazzale Santa Maria della Misericordia, 15 33100 Udine
Italy
ITEL Telecomunicazioni S.R.L.
Via Antonio Labriola Zona Industriale SNC 70037 Ruvo di Puglia (BA)
Italy
Curium Pharma Ireland Limited Blackrock Clinic
Blackrock
Co. Dublin, A94 E4X7 Ireland
Curium Pharma Spain, S.A. Thomas Alba Edison, s/n 41092 Seville
Spain
Curium Pharma Spain, S.A. Pol. Ind. Conpisa,
C/ Veguillas – 2 Nave 16,
Ajalvir 28864 (Madrid) Spain
Seibersdorf Labor GmbH Grundstueck Nr. 482/2 EZ 98 KG 2444 Seibersdorf
Austria
BetaPlus Pharma SA
Avenue Hippocrate 10 bte 1527
1200 Brussels Belgium
Institut Radiofarmacia Aplicada Barcelona-IRAB c/Doctor Aiguader 88, planta -1
08003 Barcelona
Spain
For any information about this medicine, please contact the Marketing Authorisation Holder.
The following information is intended for medical or healthcare professionals only.
The complete SmPC of Neuraceq is provided as a separate document in the product package, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical.
Please refer to the SmPC {SmPC should be included in the box}.